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Innovative Strategies For Risk Reduction Following CABG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462436
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : July 22, 2010
Canadian Diabetes Association
Information provided by:
St. Michael's Hospital, Toronto

Brief Summary:

Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals.

Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery.

Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy.

Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Type II Diabetes Mellitus Behavioral: Consumption of Dietary Portfolio Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?
Study Start Date : February 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Consumption of Dietary Portfolio
    The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.

Primary Outcome Measures :
  1. Primary Outcome: Reduction of total and LDL cholesterol [ Time Frame: baseline to 4 weeks ]

Secondary Outcome Measures :
  1. Improvement in endothelial function and EPC counts [ Time Frame: Baseline to 4 weeks ]
  2. Reduction in CRP [ Time Frame: baseline to 4 weeks ]
  3. Feasibility and tolerability [ Time Frame: Baseline to 4 Weeks ]
  4. Reduction in markers of inflammation ie TNF, IL-6 [ Time Frame: Baseline to 4 weeks ]
  5. Improved markers of glycemic control - fructosamine, HOMA [ Time Frame: baseline to 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with type II diabetes mellitus
  2. Recently (<5 months) undergone coronary artery bypass graft surgery
  3. Taking cholesterol lowering medication

Exclusion Criteria:

  1. Can not speak English and have no available interpreter
  2. Refuse Informed Consent
  3. Had "off pump" CABG
  4. Are intolerant of statins
  5. Are pre-menopausal (women) or are on HRT
  6. Have serious concomitant disease
  7. Take insulin
  8. Are <18 years of age
  9. receive incomplete revascularization
  10. documented history of drug or alcohol abuse
  11. Intend to become pregnant during study period
  12. Have an unreliable psychological condition that makes them unlikely to comply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462436

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
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Principal Investigator: Mary Keith, PhD, RD St. Michael's Hospital, Toronto
25. The Agricultural Research Service. Composition of Foods, Agriculture Handbook No 8. Washington, DC, US Department of Agriculture, 1992.
26. Association of Official Analytical Chemists. AOAC Official Methods of Analysis. Washington, DC, Association of Official Analytical Chemists, 1980.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Mary Keith, St. Michael's Hospital Identifier: NCT00462436    
Other Study ID Numbers: REB06-179C
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: February 2009
Keywords provided by St. Michael's Hospital, Toronto:
functional foods
LDL cholesterol
secondary prevention
risk reduction
endothelial function
endothelial progenitor cells
glycemic control
Additional relevant MeSH terms:
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Coronary Artery Disease
Diabetes Mellitus, Type 2
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases